Clinical Operations Lead – Pain Therapeutic Area

Job not on LinkedIn

🕒 March 27

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $135k - $160k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Provide leadership, local/global strategic planning and operational delivery of assigned clinical studies/program through all phases of study management • Ensure the effective identification, initiation and motivation of clinical study sites • Focus on internal and external customers service related to site management and clinical monitoring activities • Provide oversight and quality control review for set-up and maintenance of studies in Clinical Trial Management System (CTMS) and Trial Master File (TMF) • Plan and conduct initial and ongoing training for the study team on project-specific matters • Drive the successful activation of trial sites according to time, quality/scope and budget parameters • Serve as initial point of contact for all clinical management and monitoring issues • Develop a monitoring plan as well as monitoring tools • Collaborate with other functional departments to identify issues and risks to clinical activities • Assist with the preparation and negotiation of sites contracts/budgets and prepare payments for vendors/study sites.

🎯 Requirements

• Bachelor’s degree or RN in a life science or related field of study • Ten (10) years’ clinical research trial and/or monitoring experience • Thorough knowledge of ICH-GCP guidelines and applicable regulations • Demonstrated experience conducting clinical trials within the Pain therapeutic area (acute and chronic) • Excellent leadership skills, promoting motivation and empowerment of others • Moderate travel may be required, approximately 25% • Must maintain a valid driver’s license and be able to drive to monitor sites.

🏖️ Benefits

• medical • dental • vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • 401(k) retirement / pension plan • generous paid time off and sick leave • performance based bonus